FDA Recall
Terminated
Historical recordClass II
0.2% ROPivacaine, (Ropivacaine HCL PF, USP 500mg, 0.9% Sodium Chloride, USP QS 250 mL). Volume 250 mL. Single dose Cassette. For: Parkland Memorial Hospital. By: Advanced Pharma, 9225 Kirby Dr. Houston, TX 77054. Parkland Memorial Hospital NDC 15082-002-87
by Avella of Deer Valley, Inc. Store 38
- Reason
- Lack of Assurance of Sterility: Potential leakage of bags.
- Published
- July 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Vancomycin 1.25gm in D5W 250 mL. ( Vancomycin HCL (USP) 1.25 gm, 5% Dextrose Inj. (USP) 250 mL) Volume: 262 mL. Single dose bag. Avella Specialty Pharmacy, 24416N 19th Avenue, Phoenix, AZ 85085. NDC 42852-617-25
by Avella of Deer Valley, Inc. Store 38
- Reason
- Lack of Assurance of Sterility: Potential leakage of bags.
- Published
- July 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PHENYLephrine 40 mg (PHENYLephrine HCL (USP) 40 mg, 5%Dextrose Inj., USP 250 mL) Volume: 254 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-893-25
by Avella of Deer Valley, Inc. Store 38
- Reason
- Lack of Assurance of Sterility: Potential leakage of bags.
- Published
- July 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
NORepiNEPHrine 8 mg (norepinephrine Bitartrate (USP) 8 mg added to 5% Dextrose Inj. (USP) 250 mL. (Concentration 32 mcg/mL) Volume: 258 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-815-25
by Avella of Deer Valley, Inc. Store 38
- Reason
- Lack of Assurance of Sterility: Potential leakage of bags.
- Published
- July 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
MORphine 1 mg/mL (Morphine Sulfate, USP 100mg, 0.9% Sodium Chloride, USP QS 100 mL). Volume 100 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-241-10
by Avella of Deer Valley, Inc. Store 38
- Reason
- Lack of Assurance of Sterility: Potential leakage of bags.
- Published
- July 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Midazolam 1 mg/mL (Midazolam HCL (USP) 100 mg, Sodium Chloride, USP QS 100 mL) Volume: 100 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston TX 77054. NDC 4252-401-10
by Avella of Deer Valley, Inc. Store 38
- Reason
- Lack of Assurance of Sterility: Potential leakage of bags.
- Published
- July 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
MAGnesium 4gm in NS 100 mL (MAGnesium SULfate (USP) 4 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 108 mL. Single dose bag. For: Gaston Memorial Hospital By: Avella of Houston, 9256 Kirby Dr., Houston, TX 77054. NDC: 42852-905-10
by Avella of Deer Valley, Inc. Store 38
- Reason
- Lack of Assurance of Sterility: Potential leakage of bags.
- Published
- July 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 50 mg, 0.9% Sodium Chloride (USP) QS 50 mL) Volume: 50mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX. NDC 42852-222-65
by Avella of Deer Valley, Inc. Store 38
- Reason
- Lack of Assurance of Sterility: Potential leakage of bags.
- Published
- July 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
HEPARIN 25,000 Units in 5% Dextrose (Heparin Sodium, USP 25,000 Units, 5% Dextrose Inj., USP 250 mL) Volume: 255 mL. Single dose bag. Avella Specialty Pharmacy, 24416 N 19th Avenue, Pheonix AZ 85085. NDC 42852-729-25
by Avella of Deer Valley, Inc. Store 38
- Reason
- Lack of Assurance of Sterility: Potential leakage of bags.
- Published
- July 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
fentaNYL (10 mcg per mL) in 0.95 Sodium Chloride, USP QS 1mL. Volume 1mL. Single dose Syringe. For: Hunt Regional Medical Center, By: Advanced Pharma, 9265 Kirby Dr,., Houston, TX 77054. NDC 15082-210-70
by Avella of Deer Valley, Inc. Store 38
- Reason
- Lack of Assurance of Sterility: Potential leakage of bags.
- Published
- July 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
EPINEPHrine (USP) 4 mg, 0.9% Sodium Chloride (USP) 250 mL Volume: 254 mL single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-823-25.
by Avella of Deer Valley, Inc. Store 38
- Reason
- Lack of Assurance of Sterility: Potential leakage of bags.
- Published
- July 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
EPINEPHrine (USP) 4 mg, 5% Dextrose For Inj. (USP) 250 mL Volume: 254 mL single dose bag. For: Peninsular Regional Medical Center. By: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054. NDC 15082-855-25.
by Avella of Deer Valley, Inc. Store 38
- Reason
- Lack of Assurance of Sterility: Potential leakage of bags.
- Published
- July 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ePHEDrine 50mg, 50 mg/10 mL (5 mg per mL) (Ephedrine Sulfate, USP 50mg in 0.9% Sodium Chloride, USPQS 10mL. 10 mL-Sterile use dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-805-61
by Avella of Deer Valley, Inc. Store 38
- Reason
- Lack of Assurance of Sterility: Potential leakage of bags.
- Published
- July 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ceFAZolin 2 gm in NS 100mL. ceFAZolin Sodium (USP) 2gm, 0.9% Sodium Chloride (USP) 100mL. Volume 110 mL. Single dose bag. Avella of Houston 9265 Kirby Dr., Houston, TX 77054 NDC: 42852-604-10
by Avella of Deer Valley, Inc. Store 38
- Reason
- Lack of Assurance of Sterility: Potential leakage of bags.
- Published
- July 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
0.2% ROPivacaine - OnQ Pump, (ROPivacaine HCL (USP) 1100mg, 0.9% Sodium Chloride (USP) QS 550 ml, single dose pump. For: Vidant Medical Center, By: Avella of Houston, 9265 Kirby Dr., Houston, TX 77056. NDC: 42852-661-02
by Avella of Deer Valley, Inc. Store 38
- Reason
- Lack of Assurance of Sterility: Potential leakage of bags.
- Published
- July 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
alba BOTANICA sport mineral sunscreen (titanium dioxide 7.0% and zinc oxide 9.0%), spf 45, 170 g (6 oz) tubes packaged in a) 4 tubes per case; b) 8 pack shipper display; Manufactured By: The Hain Celestial Group, Inc., Lake Success, NY 11042, UPC 7 24742 01102 4.
by The Hain Celestial Group, Inc. - Worldwide HQ
- Reason
- Incorrect Product Formulation: wrong sunscreen product in the package.
- Published
- July 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
T R Toppers, Inc.
- Product
- TR Toppers Brand Chopped Chocolate Pretzel Pieces. Item numb…
- Reason
- Recalling TR Toppers Brand Chopped Chocolate Pretzel Pieces due to the potential for contamination with peanuts.
- Published
- July 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Piperacillin and Tazobactam for Injection USP 3.375 grams per vial, Single-Dose Vial, Rx Only. Manufactured for: Auromedics Pharma LLC 6 Wheeling Road Dayton NJ 08810, Made in India. NDC 55150-120-30
by AuroMedics Pharma LLC
- Reason
- Presence of Particulate Matter: identified as glass and silicone material
- Published
- July 18, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Gaia Kratom (mitragyna speciosa) powder, Yellow Vietnam, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
by Gaia Ethnobotanical LLC
- Reason
- Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
- Published
- July 18, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Gaia Kratom (mitragyna speciosa) powder, Yellow Thai, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
by Gaia Ethnobotanical LLC
- Reason
- Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
- Published
- July 18, 2018
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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